FDA posts Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development
Today FDA displayed a notice in the Federal Register announcing the availability of a new draft guidance for industry:
This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit correspondence to FDA requesting information related to generic drug development. This guidance also describes FDA’s process for providing communications related to such correspondence. FDA is issuing this draft guidance as part of the Agency’s implementation of the Generic Drug User Fee Amendments of 2012.
A pre-recorded webinar explaining this draft guidance is available at :
Submit electronic comments on the draft guidances to the Federal Register docket.
On July 9, 2012, the Generic Drug User Fee Amendments of 2012 (GDUFA) was signed into law by the President of the United States of America. GDUFA was designed to speed the delivery of safe, effective, and high-quality generic drugs to the public. This program will bring greater predictability and timeliness to the review of generic drug applications. GDUFA is based on an agreement negotiated by FDA and representatives of the generic drug industry.